Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
metaflumizone, amitraz
Pfizer Limited
QP53AD51
metaflumizone, amitraz
Dogs
Ectoparasiticides for topical use, incl. insecticides
For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis), and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.) and lice (Trichodectes canis) in dogs.The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Revision: 7
Withdrawn
2006-12-19
Medicinal product no longer authorised B. PACKAGE LEAFLET 33 Medicinal product no longer authorised PACKAGE LEAFLET ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Manufacturer for the batch release Wyeth Lederle Italia S.p.A. 18, Via Franco Gorgone 95121 Catania Italy 2. NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS ACTIVE SUBSTANCES Each ml contains 150 mg metaflumizone and 150 mg amitraz. Each unit dose (pipette) of ProMeris Duo delivers: VOLUME (ML) METAFLUMIZONE (MG) AMITRAZ (MG) ProMeris Duo Spot-on for Small Dogs ( ≤ 5 kg)* 0.67 100.5 100.5 ProMeris Duo Spot-on for Medium Sized Dogs - (5.1 – 10.0 kg)* 1.33 199.5 199.5 ProMeris Duo Spot-on for Medium/Large Sized Dogs (10.1 – 25.0 kg)* 3.33 499.5 499.5 ProMeris Duo Spot-on for Large Dogs (25.1 – 40.0 kg)* 5.33 799.5 799.5 ProMeris Duo Spot-on for Extra Large Dogs (40.1 – 50.0 kg)* 6.66 999 999 34 Medicinal product no longer authorised *DUE TO LIMITED SPACE ON THE PACKAGING, THE ABBREVIATIONS "S", "M", "M/L", "L" AND "XL", WHICH REPRESENT "SMALL", “MEDIUM”,” MEDIUM/LARGE”, “LARGE” AND “EXTRA LARGE”, RESPECTIVELY, ARE USED ON THE BLISTER FOIL AND APPLICATOR PIPETTES. 4. INDICATION(S) For the treat সম্পূর্ণ নথি পড়ুন
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES Each ml contains 150 mg metaflumizone and 150 mg amitraz. Each unit dose (pipette) of ProMeris Duo delivers: PROMERIS DUO SPOT-ON FOR DOGS VOLUME (ML) METAFLUMIZONE (MG) AMITRAZ (MG) for Small Dogs ( ≤ 5 kg) 0.67 100.5 100.5 for Medium Sized Dogs - (5.1 – 10.0 kg) 1.33 199.5 199.5 for Medium/Large Sized Dogs (10.1 – 25.0 kg) 3.33 499.5 499.5 for Large Dogs (25.1 – 40.0 kg) 5.33 799.5 799.5 for Extra Large Dogs (40.1 – 50.0 kg) 6.66 999 999 EXCIPIENTS For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution A clear, yellow to amber solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs over 8 weeks of age 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and prevention of infestations by fleas ( _Ctenocephalides canis and C. felis_ ), and ticks ( _Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus and _ _Dermacentor _ _variabilis_ ), and treatment of demodicosis (caused by _Demodex _ spp _._ ) and lice ( _Trichodectes canis_ ) in dogs. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). 4.3 CONTRAINDICATIONS Do not administer to puppies under 8 weeks of age. Do not administer to cats Do not administer to sick or debilitated dogs or dogs suffering from heat stress. 2 Medicinal product no longer authorised 4.4 SPECIAL WARNINGS Avoid contact with the eyes of the dog and avoid oral ingestion by the dog. The veterinary medicinal product remain সম্পূর্ণ নথি পড়ুন